BioSpace News Archive

Policy

Lawmakers Push for Medicare Coverage of Weight-Loss Drugs

Amid high rates of U.S. obesity, a bipartisan bill has been reintroduced in the Senate and House of Representatives with backing from Eli Lilly, Novo Nordisk and Boehringer Ingelheim.

July 21, 2023
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2 min read
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Tristan Manalac
FDA

Daiichi Sankyo’s FLT3 Inhibitor Gets FDA Nod as First-Line AML Treatment

After being rejected by an FDA advisory panel four years ago, Vanflyta is now approved across three phases of treatment for acute myeloid leukemia patients with the FLT3 gene mutation.

July 21, 2023
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2 min read
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Kate Goodwin
FDA

FDA Greenlights 35 Novel Approvals in H1, Biologics Stand Out

The FDA’s CBER approved nine novel therapies in the first half of 2023, with several more high-profile decisions on deck for the second half of the year.

July 21, 2023
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4 min read
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Heather McKenzie
Drug Development

Plasma and Cell and Gene Therapy Milestones Highlight R&D Growth at CSL

CSL’s AEGIS-II trial and cell and gene therapy expansion highlight the significant global expansion within the company over the past five years.

July 21, 2023
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4 min read
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Caleigh Findley
Drug Development

ADC Discontinues Zynlonta Trial in DLBCL After Seven Deaths

Following seven patient deaths in a Phase II study, ADC Therapeutics is discontinuing the development of its Zynlonta antibody-drug conjugate—combined with Rituxan—for diffuse large B-cell lymphoma.

July 21, 2023
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2 min read
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Tristan Manalac
Drug Development

Vir’s GSK-Backed Flu Vaccine Candidate Fails Phase II Trial

Even at its highest dose, Vir Biotechnology’s investigational flu shot failed to significantly outperform placebo at preventing influenza A illness in a mid-stage study.

July 21, 2023
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2 min read
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Tristan Manalac
Business

Week in Review: FTC Gets Tougher on Mergers, AAIC Data Dump, and J&J’s Q2 Beat

The Federal Trade Commission released new draft guidelines for assessing mergers, while an Alzheimer’s conference yielded promising data and J&J kicked off Q2 earnings season with a sound beat.

July 21, 2023
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2 min read
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Greg Slabodkin
Deals

Turnstone Biologics Corp. Announces Pricing of Upsized Initial Public Offering - July 21, 2023

Turnstone Biologics Corp. announced the pricing of its upsized initial public offering of 6,666,667 shares of common stock at a price to the public of $12.00 per share.

July 21, 2023
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3 min read
Biovica achieves PLA code for Medicare

Biovica International Biovica, active in cancer monitoring, announces that the company has received a PLA code from the AMA, an important milestone in the commercialization of DiviTum® TKa in the United States.

July 21, 2023
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2 min read
Portzamparc Groupe BNP Paribas Initiates the Coverage of Median Technologies with a “Strong Buy” Recommendation

Median Technologies announces the publication of an initiation report by Portzamparc Groupe BNP Paribas, a French leading group covering brokerage for Individual and institutional investors, and financial operations for corporate and Institutional clients.

July 21, 2023
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2 min read